Pharma SME

3 weeks ago

Mumbai, India UsefulBI Corporation Full time

We are hiring Pharma SME - Medical Writing Experience: 5-8 years Industry: Pharmaceutical Shift Timing: 2 pm to 11 pm Locations: Pune/Bangalore/Lucknow Key Responsibilities: - Develop, review, and finalize scientific and regulatory documents including clinical study reports (CSRs), protocols, investigator brochures (IBs), and safety narratives. - Ensure all documents adhere to ICH-GCP, regulatory, and company standards. - Translate complex clinical data into clear, concise, and scientifically accurate documents. - Collaborate with cross-functional teams including clinical research, medical affairs, and regulatory affairs for content accuracy. - Provide guidance and mentorship to junior medical writers and ensure quality control of deliverables. Skills & Competencies: - Proficiency in scientific writing and regulatory documentation. - Sound understanding of clinical trial phases, statistical concepts, and medical terminology. - Strong editorial, grammar, and formatting skills with attention to detail.

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